ID
32979
Description
Study ID: 101877 Clinical Study ID: SAS101877 Study Title: A randomised, open label, 5-way crossover study to assess the systemic exposure of FP and salmeterol from SERETIDE/ADVAIR 250 without spacer, with Aerochamber -Plus and with -Max spacer, with VOLUMATIC spacer and SERETIDE/ADVAIR 500 DISKUS/ACCUHALER in adult subjects with mild or intermittent asthma Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: fluticasone propionate/salmeterol Trade Name: Advair DISKUS,Seretide Accuhaler; Viani,Seretide Diskus,Seretide Accuhaler,Seretide,Advair DISKUS Study Indication: Asthma The study consists of 5 treatment periods and a follow-up visit. The Screening includes Session 1 Treatment Period 1 includes Session 2 Treatment Period 2 includes Session 3 Treatment Period 3 includes Session 4 Treatment Period 4 includes Session 5 Treatment Period 5 includes Session 6 The Follow-up includes Session 7. This document contains the end of study, Investigator Comment Log and Investigator’s Statement form. It has to be filled in at the end of study (after all relevant CRF pages, including outstanding test results, are completed).
Keywords
Versions (3)
- 11/22/18 11/22/18 -
- 11/22/18 11/22/18 -
- 11/23/18 11/23/18 -
Copyright Holder
GlaxoSmithKline
Uploaded on
November 22, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Systemic exposure of fluticasone propionate (FP) and salmeterol from different inhalation devices in adults with mild or intermittent asthma, (Study-)ID: 101877
End of study, Investigator Comment Log, Investigator’s Statement
- StudyEvent: ODM
Description
End of Study Record
Alias
- UMLS CUI-1
- C0008976
- UMLS CUI-2
- C0444930
Description
day month year
Data type
date
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0011008
- UMLS CUI [2,1]
- C0457454
- UMLS CUI [2,2]
- C0008976
- UMLS CUI [2,3]
- C0011008
Description
00:00-23:59
Data type
time
Alias
- UMLS CUI [1,1]
- C2348577
- UMLS CUI [1,2]
- C0040223
- UMLS CUI [2,1]
- C0457454
- UMLS CUI [2,2]
- C0040223
Description
Tick one. If YES, record details on PREGNANCY NOTIFICATION FORM.
Data type
text
Alias
- UMLS CUI [1]
- C0032961
Description
If YES, record details on the MEDICAL DEVICE INCIDENT REPORT FORM.
Data type
text
Alias
- UMLS CUI [1,1]
- C0025080
- UMLS CUI [1,2]
- C1551358
Description
Discontinuation of study
Data type
text
Alias
- UMLS CUI [1,1]
- C0457454
- UMLS CUI [1,2]
- C0008976
Description
Tick one. If A: Record details on NON-SERIOUS ADVERSE EVENTS or SERIOUS ADVERSE EVENT page as appropriate.
Data type
text
Alias
- UMLS CUI [1,1]
- C0392360
- UMLS CUI [1,2]
- C0457454
- UMLS CUI [1,3]
- C0008976
Description
Other reason
Data type
text
Alias
- UMLS CUI [1]
- C3840932
Description
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Description
Date of comment
Data type
date
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0011008
Description
CRF page number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C1516308
Description
Comment
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Investigator’s Statement
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C1710187
Description
I confirm that I have carefully examined all entries on the Screening Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, correct as of the date below.
Data type
boolean
Alias
- UMLS CUI [1]
- C0750484
Description
day month year
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Investigator’s signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator’s name - print
Data type
text
Alias
- UMLS CUI [1]
- C2826892
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End of study, Investigator Comment Log, Investigator’s Statement
- StudyEvent: ODM
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